UMIN-CTR Clinical Trial

Basic information
Public title	A study for probiotics supplementation effect on lactating women.
Acronym	A study for probiotics supplementation effect on lactating women.
Scientific Title	A study for probiotics supplementation effect on lactating women.
Scientific Title:Acronym	A study for probiotics supplementation effect on lactating women.
Region	Japan

Condition
Condition	Lactating women with allergies
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the tolerance and effects of probiotics(Lactobacillus casei LC5 strain 5 billion cfu, Bifidobacterium longum BG7 strain 5 billion cfu, and Bacillus coagulans SANK70258 strain 0.2 billion cfu) supplementation on TGF-b and IgA levels in human milk of lactating women with allergies in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Health condition monitoring based on self-reported diary throughout the study periods.
Key secondary outcomes	Adherence of intervention. TGF-b and IgA in human milk. Other components in human milk. Lifestyle-associated factors. Dietary patterns based on food frequency questionnaire.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	3 tablets once a day after breakfast for 2 months (1-3 months postpartum).
Interventions/Control_2	No-intervention control in 2 months (1-3 months postpartum).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	50 years-old >
Gender	Female
Key inclusion criteria	1) Lactating 2) 30 days to 59 days postpartum 3) A history of allergy at recruitment. The maternal allergy history was determined based on a reported clinical history of atopic eczema, asthma, or allergic rhinitis.
Key exclusion criteria	1) Clinical evidence of chronic illness or gastrointestinal disorder. 2) Routine use of any other dietary supplements containing probiotics and fiber. 3) Smoking at recruitment.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Taku Nakano
Organization	Bean Stalk snow Co., Ltd.
Division name	Research and Development Department
Zip code
Address	1-1-2 Minamidai, Kawagoe, Saitama, Japan
TEL	049-242-8138
Email	nakano@meg-snow.com

Public contact
Name of contact person	1st name Middle name Last name Hirofumi Fukudome
Organization	Bean Stalk snow Co., Ltd.
Division name	Research and Development Department
Zip code
Address	1-1-2 Minamidai, Kawagoe, Saitama, Japan
TEL	049-242-8138
Homepage URL
Email	h-fuku@beanstalksnow.co.jp

Sponsor
Institute	Bean Stalk snow Co., Ltd. Research and Development Department
Institute
Department

Funding Source
Organization	Bean Stalk snow Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 01 Day

Related information
URL releasing protocol	https://www.frontiersin.org/articles/10.3389/fnut.2019.00128/full
Publication of results	Published

Result
URL related to results and publications	https://www.frontiersin.org/articles/10.3389/fnut.2019.00128/full
Number of participants that the trial has enrolled	60
Results	No adverse effects were observed in the probiotic group, according to the self-recorded diary during the study period. Milk IgA decreased with increasing postpartum months in both groups. In contrast, TGF-b1 and b2 were not affected by lactation periods, and showed different patterns over time between the two groups. TGF-b1, TGF-b1, and IgA levels were significantly correlated at baseline. However, the correlation between TGF-b1 and IgA became non-significant by the end of the intervention.
Results date posted	2022 Year 09 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 09 Month 03 Day
Baseline Characteristics	https://www.frontiersin.org/articles/10.3389/fnut.2019.00128/full DOI: 10.3389/fnut.2019.00128
Participant flow	https://www.frontiersin.org/articles/10.3389/fnut.2019.00128/full DOI: 10.3389/fnut.2019.00128
Adverse events	https://www.frontiersin.org/articles/10.3389/fnut.2019.00128/full DOI: 10.3389/fnut.2019.00128
Outcome measures	https://www.frontiersin.org/articles/10.3389/fnut.2019.00128/full DOI: 10.3389/fnut.2019.00128
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 19 Day
Date of IRB	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 05 Month 17 Day
Last follow-up date	2014 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 01 Day
Last modified on	2022 Year 09 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041053